Immunogenicity of Influenza Vaccines in HIV-infected Persons in Thailand

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ClinicalTrials.gov Identifier: NCT01538940

Recruitment Status
: Unknown

Verified September 2012 by Centers for Disease Control and Prevention. Recruitment status was: Recruiting

This study will assess the efficacy of a new intradermal formulation of the trivalent inactivated influenza vaccine compared to the standard intramuscular vaccine in HIV-infected men who have sex with men in Bangkok, Thailand. Relative efficacy of the two different formulations of influenza vaccine will be assessed by comparing immunologic responses to vaccine between the two study arms.

Randomized Controlled Trial to Compare the Immunogenicity of Intramuscular Versus Intradermal Trivalent Inactivated Split Virion Influenza Vaccine in HIV-infected Men Who Have Sex With Men in Bangkok, Thailand

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Men with severe allergies to chicken eggs (they will specifically be asked about severe egg allergies during the screening visit; appendix C1)

Men > 60 years of age

Men who have had a severe reaction to influenza vaccine in the past

Men with a history of Guillain-Barré Syndrome

Men who received influenza vaccine within 12 months prior to enrollment

Men who are on steroid therapy or other immunosuppressant medications

Men who received any vaccine in the 4 weeks prior to the first study visit or who plan to receive a vaccine (other than influenza vaccine provided through the study protocol) in the 4 weeks following the first study visit

Men who received an experimental agent (vaccine, drug, biologic, device, blood product, medication) within 1 month prior to enrollment in this study, or expect to receive an experimental agent during the 12 month study period

Men who have any condition, in the opinion of the investigator, that would place them at an unacceptable risk of injury or render them unable to meet requirements of the protocol. (e.g., severe reaction to another vaccine, blood clotting disorder, inflammatory skin condition).